The Medicines Patent Pool Ellen ‘t Hoen UNITAID Consultative Forum Geneva, 4-5 October 2011.

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Presentation transcript:

The Medicines Patent Pool Ellen ‘t Hoen UNITAID Consultative Forum Geneva, 4-5 October 2011

$10,400$2700 Generic Competition & Treatment Scale-Up

TRIPS Transition for Developing Countries TRIPS Transition for Least Developed Countries Zidovudine Didanosine Stavudine Saquinavir Nevirapine Abacavir Emtricitabine Indinavir Efavirenz ` Lopinavir Atazanavir Tenofovir DF Fosamprenavir Maraviroc Etravirine Rilpivirine Elvitegravir Heat-stable ritonavir Raltegravir Dolutegravir Cobicistat SPI Changing ARV Patent Landscape

Pool Sub- Licensee Royalties Patents Licensor Generics version of existing compounds FDCs Adapted formulations (e.g. paediatrics ) The Medicines Patent Pool Established in 2010 with the support of

Company Engagement Patent HolderQ4 2010Q1 2011Q2 2011Q Abbott Laboratories Sent letter on 1 December Not currently in negotiations. Reply received 26 January Not currently in negotiations. Not currently in negotiations Boehringer- Ingelheim Sent letter on 1 December Not currently in negotiations. Reply received 19 January Not currently in negotiations. In negotiations. Bristol-Myers Squibb Sent letter on 1 December Not currently in negotiations. Reply received 26 January Not currently in negotiations. In negotiations. F. Hoffman-La Roche Sent letter on 1 December Preparing for negotiation.In negotiations. Gilead Sciences Sent letter on 1 December In negotiations. Reply received 14 February In negotiations.Licence agreement signed July Merck & Co. Sent letter on 1 December Not currently in negotiations. Reply received 28 January Not currently in negotiations. Sequoia Pharmaceuticals In negotiations. Tibotec/Johnson & Johnson Sent letter on 1 December Not currently in negotiations. Reply received 31 January Not currently in negotiations. US NIH Licence agreement signed Sept In negotiations. ViiV Healthcare Sent letter on 1 December In negotiations. In formal negotiationsLicence agreement signed

Pool/Gilead Agreement Key Features: Includes: TDF, 3 pipeline drugs: cobicistat (COBI), elvitegravir (EVG) and Quad; retains covenant not to sue on emtricitabine (FTC) Pipeline products inclusion will help accelerate bringing new products to market Licensed Territory: for TDF, expanded to 112 countries; for COBI, changed to 103 countries; for EVG-Quad, 100 countries. Licensees free to make any combination product (except EVG, where Gilead’s licensor JT required Gilead prior approval) Royalties 3 % for TDF and 5% for the others, 0% pediatric formulations Paediatric formulations: royalties waived for any paediatric formulations developed by licensee; allows for paediatric formulations to be made available outside Territory via licence to Gilead distributors, with appropriate compensation to licensee Waiver of any data exclusivity rights, where applicable Licensee can pick and choose licences (agreement is not bundled) Provisions to ensure ability of Sub-licensees to supply countries outside the territory where a compulsory license for export has been issued One time tech transfer (but with no extra obligation to pay royalty) Provides for publication of licence agreement Concerns: Limited to licensees based in India Sourcing of API Geographical scope

Geographical Scope Largest Geographical scope of any VL to date TDF: 112 countries (87.6%) COB: 103 (82.7%) EVG and Quad: 100 countries (82.7%) A recognized shortcoming in the licence Most difficult issue in negotiations with patent holders Ask: all low and middle income countries. But Pool is a voluntary mechanism Make as many people as possible better off, while ensuring no country worse off than status quo ante E.g. Important that licensees can supply countries under a CL 7

8 Current voluntary licensing geographic scope: numbers of countries included

9 Pool/Gilead license: PLHIV population breakdown by income-group & drug

Concluding comments License with Gilead not a template – agreements with other companies are likely to be different we will continue to work on improvements of existing licenses We benefit from comments we receive and public debate on the licenses UNITAID UNITAID with others to encourage all HIV patent holders to enter into negotiations with the Pool IP goes beyond access -> role in innovation - I+A agenda -> encourage uptake of licenses encourage and steer/create the market for the development of adapted formulations To develop an i+a agenda beyond the pool Put challenges for middle income countries on the agenda

THANK YOU